Study on Wood-plastic Composite for Circumferential Casting

Bone Fracture Clinical Trial

— WOODCAST  

Official title:

Study on Circumferential Casting Techniques With WOODCAST

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01493167
• Other study ID #: 37/13/03/02/2011
• Status: Completed
• Phase: N/A
• First received: December 13, 2011
• Last updated: December 3, 2014
• Start date: December 2011
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Onbone Oy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Valvira - National Supervisory Authority for Welfare and Health
• Study type: Observational

Clinical Trial Summary

The purpose of study is to verify that WOODCAST Circular system performs safely and effectively in its intended use.

Description:

An ecologically friendly and biodegradable wood-plastic composite-cast is studied. The purpose of the study is to verify that WOODCAST Circular system performs safely and effectively in its intended use. Patients, who need immobilization of extremity (including for example scaphoid fracture of the wrist or ankle fracture) will be participating in the study. Various casting techniques with novel WOODCAST material will be studied.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 90 Years

Eligibility

Inclusion Criteria:

• patient treatment involves circular casting;

• age 0-90 years;

• mother tongue finnish or swedish

Exclusion Criteria:

• open fracture;

• other fractures or a previous fracture;

• a previous or simultaneous tendon-, nerve-, or vascular injury to the extremity yo be treated;

• a multiple injured extremity;

• decreased co-operation of the patient;

• malignancy;

• an illness affecting the general health.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ankle Fracture
• Ankle Fractures
• Bone Fracture
• Fractures, Bone
• Radius Fracture
• Radius Fractures

Intervention

Other:
• limb casting/splinting
ankle and arm cast

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Onbone Oy

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy study for new design of scafoideum and ankle casts.		1 - 6 weeks	No